M12A Enterprise Holter System

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Study Management
  • M12A supports multiple independent studies
  • User login selects which study to access
  • Study centric configuration setting for monitoring modes
  • Study centric demographic entry rules
  • Study centric QT Epoch requirements
Acquisition Station
  • Simple Acquisition wizard
  • Bluetooth or SD card device initialization
  • Patient/Subject demographic entry or search central site for information.
  • Provides a list of active recording devices allowing immediate connection
  • Monitored ECG data segments can be printed, reviewed and analyzed locally, then saved to central site
  • Remote access allows connecting and acquiring segments of data
  • Each segment of data and/or the entire recording can be saved to the central site
  • Acquisition station exchanges data with central site via the internet
Data Review Station
  • Includes all acquisition station features
  • Provides site centric list of subjects
  • Review/Editing tool allows access to all the ECG data
  • Traditional Arrhythmia Holter Analysis program
  • 12-Lead Interpretive Analysis
  • QT Analysis program
  • Full report including 12-lead standard
  • Export HL7 XML for QT and ISHNE format
  • Data reviewer station exchanges data with central site via the internet
Central Site Data Management
  • Back-end application for collecting information from remote sites
  • SQL database
  • User security management
  • Remote Client Software versioning management
  • 21 CFR Part 11 compliance audit system

The M12A Enterprise Holter System provides a suite of data management, analysis and acquisition software modules for wide area network applications. The M12A provides the capability to manage data acquisition, data analysis and data storage functions required for Hospital or Clinical Research Study applications. The M12A is scalable to support multiple studies. This model contains the same operational capabilities as Cardiology Office Holter System but with much more extensible features.

The Enterprise Holter System software architecture allows for multiple remote sites to exchange data over the internet to a central site (including full support of wireless internet connectivity options). The remote site application is intended to operate with the M3R 3-channel or M12R 12-lead ECG Holter monitor device. The M12A Enterprise Holter System, using an advanced security, can be configured to support Study Management Stations, Data Acquisition Stations and Data Reviewer Stations. The central site provides back-end support for collection of data from the remote sites/stations, security management and other administrative features.

The M12A Data Acquisition Station and Data Reviewer Station client software runs on a PC and uses an internet connection to transfer data to the back-end server.

The principal function of the M12A Data Acquisition Station is to manage the initialization, monitoring and uploading of data to the central site. For initializing the device the Data Acquisition Station can use an SD card or Bluetooth wireless interface. During actual acquisition the station can connect to the active device using a wireless interface to collect and present ECG data in real-time on the PC display. This ECG data can be locally reviewed, analyzed, printed and saved to the central site. This provides users at other sites with the ability to view and analyze the data shortly after it has been received at the central site.

The M12A software system is modular, enabling each system component to be run on different PC’s at different locations throughout the world to support worldwide collaborative applications. This modular configurability enables the M12A to support requirements for virtually any study.